What is the regulatory pathway for ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

Q: Who is the manufacturer of ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT?

Alfa Wassermann Diagnostics Technologies, LLC filed the 510(k) submission for ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT (K123322).

Q: What is the FDA product code for ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT?

CDN. It is classified under 21 CFR 862.1770 as a Class 2 device in the Clinical Chemistry panel.

K123322 · Alfa Wassermann Diagnostics Technologies, LLC · CDN · May 21, 2013 · Clinical Chemistry

Device Facts

Record ID	K123322
Device Name	ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
Applicant	Alfa Wassermann Diagnostics Technologies, LLC
Product Code	CDN · Clinical Chemistry
Decision Date	May 21, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1770
Device Class	Class 2

Intended Use

The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Story

Reagents for quantitative in vitro diagnostic analysis of serum and lithium heparin plasma samples; used on ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Principle of operation: photometric analysis of chemical reactions (hydrolysis, colorimetric complex formation, or enzymatic NAD/NADP reduction/oxidation). Systems monitor absorbance changes at specific wavelengths (e.g., 340 nm, 505 nm) to calculate analyte concentration or enzyme activity. Operated by laboratory personnel in clinical or physician office settings. Output provided as concentration or activity values to assist clinicians in diagnosing and monitoring renal, metabolic, and muscle disorders. Benefits include rapid, automated diagnostic testing for patient management.

Clinical Evidence

Bench testing only. Precision evaluated via 20-day studies and POL site studies. Linearity confirmed across reportable ranges. Method comparison (N=49-53 per analyte) against predicate showed high correlation (r² > 0.99). Matrix comparison (serum vs. lithium heparin plasma) confirmed equivalence across all three analyzer platforms. Interference testing performed per CLSI EP07-A2.

Technological Characteristics

Photometric/colorimetric enzymatic assays. Reagents include urease, GLDH, picric acid, uricase, peroxidase, hexokinase, and G-6-PDH. Systems utilize bichromatic monitoring at specific wavelengths (e.g., 340nm, 505nm). Traceable to NIST SRM 909/967. Designed for use on ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems.

Indications for Use

Indicated for quantitative determination of BUN, creatinine, uric acid, and creatine kinase in serum and lithium heparin plasma for diagnosis/treatment of renal, metabolic, and muscle diseases in clinical/physician office labs.

Regulatory Classification

Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Predicate Devices

Alfa Wassermann ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, and ACE CK Reagents (K930104)

Related Devices

K131488 — ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT · Alfa Wassermann Diagnostics Technologies, LLC · Aug 19, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ .12 3322 ## 510(k) SUMMARY # MAY 2 1 2013 1 | 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC 4 Henderson Drive West Caldwell, NJ 07006 | | | |---------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--| | Contact: | Hkatz@AlfaWassermannUS.com Hyman Katz, Ph.D. Phone: 973-852-0158 Fax: 973-852-0237 | | | | Date Summary Prepared: | May 14, 2013 | | | | Device: | Trade Name: | ACE BUN/Urea Reagent | | | | Classification: | Class 2 | | | | Common/Classification Name: | Urease, Photometric, Urea Nitrogen (21 C.F.R. § 862.1770) Product Code CDN | | | | Trade Name: | ACE Creatinine Reagent | | | | Classification: | Class 2 | | | | Common/Classification Name: | Alkaline Picrate, Colorimetry, Creatinine (21 C.F.R. § 862.1225) Product Code CGX | | | | Trade Name: | ACE Uric Acid Reagent | | | | Classification: | Class 1, reserved | | | | Common/Classification Name: | Acid, Uric, Uricase (Colorimetric) (21 C.F.R. § 862.1775) Product Code KNK | | | | Trade Name: | ACE CK Reagent | | | | Classification: | Class 2 | | | | Common/Classification Name: | NAD Reduction/NADH Oxidation, CPK Or Isoenzymes (21 C.F.R. § 862.1215) Product Code CGS | | な {1}------------------------------------------------ | Predicate Devices: | Alfa Wassermann ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, and ACE CK Reagents (K930104) | Intended Use: | Indications for Use: | Technological Characteristics: | The ACE BUN/Urea Reagent consists of a single reagent bottle. The reagent contains α- ketoglutarate, urease, glutamate dehydrogenase, adenosine diphosphate (ADP), nicotinamide adenine dinucleotide and reduced (NADH). | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Descriptions: | In the ACE BUN/Urea Reagent assay, urea in serum is hydrolyzed in the presence of urease to yield ammonia and carbon dioxide. The ammonia formed then reacts in the presence of glutamate dehydrogenase with 2-oxoglutarate and NADH to yield glutamate and NAD. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rate of decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportional to the urea concentration in the sample. | | The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | | The ACE Creatinine Reagent consists of two reagent bottles. The Sodium Hydroxide Reagent (R1) contains sodium hydroxide. The Picric Acid Reagent (R2) contains picric Acid. | | | In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkaline medium to form a red-orange colored complex, which absorbs strongly at 505 nm. The rate of complex formation, determined by measuring the increase in absorbance bichromatically at 505 nm/573 nm during a fixed time interval, is directly proportional to the creatinine concentration in the sample. | | The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | | The ACE Uric Acid Reagent consists of a single reagent bottle. The reagent contains 4- aminoantipyrine, dichlorohydroxybenzene sulfonic acid, peroxidase and uricase. | | | In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by uricase to allantoin and hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple dichlorohydroxybenzene sulfonic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex, which absorbs strongly at 505 nm. The amount of chromogen formed is determined by measuring the increase in absorbance bichromatically at 505 nm/610 nm, and is directly proportional to the uric acid concentration in the sample. | | The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | | The ACE CK Reagent consists of two reagent bottles. The Buffer Reagent (R1) contains: imidazole buffer, glucose, N-acetyl-cysteine, magnesium acetate, EDTA, NADP and hexokinase. The Substrate Reagent (R2) contains: creatine phosphate, ADP, AMP, diadenosine pentaphosphate, EDTA and glucose-6-phosphate dehydrogenase. | | | In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6- phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK in the sample. | | The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | | | and and the comments of the country and the control of the country of the county of the county of and the control control of the control of the control of . - . · 。 {2}------------------------------------------------ . : {3}------------------------------------------------ Device Comparison with Predicate #### Comparison of similarities and differences with predicate device . | BUN/Urea | Candidate Device | Predicate Device K930104 (ACE BUN/Urea) | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Intended Use/ Indications for Use | The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration. | Same | | Platforms | ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems | ACE Clinical Chemistry System | | Method | Photometric | Same | | Calibration Stability | 7 days | Same | | On-Board Stability | 30 days | Same | | Sample Type | Serum and lithium heparin plasma | Serum | | Sample Volume | 3 µL | Same | | Reaction Volume | 333 µL | Same | | Expected Values | 6 - 20 mg/dL | Same | | Measuring Range | 3 - 100 mg/dL | Same | | Sample Stability | Samples may be stored for 7 days at 4-8°C and for 1 year at -20 °C. | Same | ## ACE BUN/Urea Reagent {4}------------------------------------------------ # Device Comparison with Predicate ## ACE Creatinine Reagent | Creatinine | Candidate Device | Predicate Device K930104 (ACE Creatinine) | |--------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------| | Intended Use/ Indications for Use | The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration. | Same | | Platforms | ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems | ACE Clinical Chemistry System | | Method | Photometric | Same | | Calibration Stability | 2 days | Same | | On-Board Stability | 10 days | Same | | Sample Type | Serum and lithium heparin plasma | Serum | | Sample Volume | 20 µL | Same | | Reaction Volume | 240 µL | Same | | Expected Values | Female: 0.6-1.1 mg/dL Male: 0.9-1.3 mg/dL | Same | | Measuring Range | 0.33 - 25.0 mg/dL | Same | | Sample Stability | Creatinine is stable for 7 days when refrigerated at 4- 8 °C and for 3 months frozen at -20 °C. | Same | ## ACE Uric Acid Reagent | Uric Acid | Candidate Device | Predicate Device K930104 (ACE Uric Acid) | |--------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------| | Intended Use/ Indications for Use | The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity. | Same | | Platforms | ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems | ACE Clinical Chemistry System | | Method | Photometric | Same | | Calibration Stability | 30 Days | Same | | On-Board Stability | 30 Days | Same | | Sample Type | Serum and lithium heparin plasma | Serum | | Sample Volume | 3 µL | Same | | Reaction Volume | 243 µL | Same | | Expected Values | Female: 2.6-6.0 mg/dL Male: 3.5-7.2 mg/dL | Same | | Measuring Range | 1.5 - 16.0 mg/dL | Same | | Sample Stability | Separated from cells, uric acid is stable for 3-5 days at 4 °C and for 6 months frozen at -20°C. | Same | 5 . {5}------------------------------------------------ | Device Comparison with Predicate | ACE CK Reagent | | | |----------------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------| | | Creatinine Kinase | | | | | Candidate Device | Predicate Device K930104 (ACE CK) | | | | Intended Use/ Indications for Use | ACE Magnesium Reagent is intended for the quantitative determination of magnesium. | Same | | | Platforms | ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems | ACE Clinical Chemistry System | | | Method | Photometric | Same | | | Calibration Stability | Not Applicable | Same | | | On-Board Stability | 25 Days | Same | | | Sample Type | Serum and lithium heparin plasma | Serum | | | Sample Volume | 5 µL | Same | | | Reaction Volume | 170 µL | Same | | | Expected Values | Female: 26-140 U/L Male: 38-174 U/L | Same | | | Measuring Range | 11 - 1350 U/L | | | | Sample Stability | Serum magnesium is stable for 7 days at 4-8°C and 1 year at -20 °C if the serum is separated from the erythrocytes. | Same | . : {6}------------------------------------------------ Performance Data: In-House Precision -Serum vs. Plasma ## Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems #### In-House Precision: Serum vs. Plasma – ACE BUN/Urea Reagent | Precision (SD, %CV) | | | | | | | | | | | |---------------------|-------------|----------------|------------|---------------|----------------|------------|---------------|----------------|------------|--| | BUN mg/dL | ACE Mean | Within- Run | Total | Alera Mean | Within -Run | Total | Axcel Mean | Within- Run | Total | | | Serum Low | 5 | 0.5, 11.1% | 0.6, 12.4% | 5 | 0.4, 7.9% | 0.6, 13.6% | 4 | 0.4, 8.1% | 0.5, 12.1% | | | Serum Mid | 46 | 0.7, 1.4% | 0.9, 1.8% | 46 | 0.4, 0.9% | 0.7, 1.5% | 45 | 0.6, 1.2% | 0.7, 1.5% | | | Serum High | 85 | 2.4, 2.8% | 2.7, 3.2% | 85 | 1.4, 1.6% | 1.8, 2.1% | 85 | 1.3, 1.5% | 1.7, 2.0% | | | Plasma Low | 4 | 0.4, 10.7% | 0.5, 12.8% | 4 | 0.0, 0.0% | 0.0, 0.0% | 4 | 0.3, 6.3% | 0.3, 6.3% | | | Plasma Mid | 46 | 0.4, 0.9% | 0.7, 1.5% | 45 | 0.5, 1.1% | 0.9, 1.9% | 45 | 0.6, 1.4% | 0.6, 1.4% | | | Plasma High | 85 | 2.9, 3.4% | 3.2, 3.8% | 85 | 1.3, 1.5% | 1.6, 1.9% | 84 | 1.8, 2.2% | 1.9, 2.3% | | ## In-House Precision: Serum vs. Plasma – ACE Creatinine Reagent | Creatinine mg/dL | ACE Mean | Within- Run | Total | Alera Mean | Within- Run | Total | Axcel Mean | Within- Run | Total | |---------------------|-------------|----------------|------------|---------------|----------------|------------|---------------|----------------|------------| | Serum Low | 0.67 | 0.04, 5.8% | 0.06, 8.5% | 0.70 | 0.02, 3.2% | 0.04, 5.6% | 0.70 | 0.04, 6.0% | 0.06, 8.1% | | Serum Mid | 9.32 | 0.28, 3.0% | 0.28, 3.0% | 9.24 | 0.21, 2.3% | 0.22, 2.4% | 9.31 | 0.16, 1.7% | 0.19, 2.1% | | Serum High | 18.25 | 0.13, 0.7% | 0.35, 1.9% | 17.96 | 0.18, 1.0% | 0.22, 1.2% | 17.97 | 0.14, 0.8% | 0.23, 1.3% | | Plasma Low | 0.65 | 0.04, 6.3% | 0.06, 9.0% | 0.66 | 0.04, 5.5% | 0.05, 7.8% | 0.64 | 0.04, 6.6% | 0.06, 9.3% | | Plasma Mid | 9.47 | 0.23, 2.5% | 0.25, 2.7% | 9.41 | 0.23, 2.5% | 0.23, 2.5% | 9.42 | 0.19, 2.0% | 0.25, 2.6% | | Plasma High | 18.38 | 0.20, 1.1% | 0.45, 2.4% | 18.04 | 0.19, 1.0% | 0.22, 1.2% | 18.13 | 0.31, 1.7% | 0.43, 2.4% | {7}------------------------------------------------ ## In-House Precision: Serum vs. Plasma – ACE Uric Acid Reagent Performance Data: In-House Precision -Serum vs. Plasma | Precision (SD, %CV) | | | | | | | | | | | |---------------------|-------------|----------------|-----------|---------------|----------------|-----------|---------------|----------------|-----------|--| | Uric Acid mg/dL | ACE Mean | Within- Run | Total | Alera Mean | Within- Run | Total | Axcel Mean | Within- Run | Total | | | Serum Low | 4.5 | 0.1,2.6% | 0.2, 4.5% | 4.5 | 0.1,3.0% | 0.2. 4.6% | 4.5 | 0.1, 1.5% | 0.2.4.4% | | | Serum Mid | 9.3 | 0.1, 1.3% | 0.2, 2.5% | 9.2 | 0.1, 0.8% | 0.2, 2.6% | 9.3 | 0.1. 0.9% | 0.3. 2.8% | | | Serum High | 15.0 | 0.3, 1.8% | 0.3, 2.0% | 14.8 | 0.3, 1.9% | 0.3, 2.1% | 14.9 | 0.2, 1.1% | 0.3, 1.8% | | | Plasma Low | 4.3 | 0.2, 3.6% | 0.2、5.5% | 4.3 | 0.1,3.3% | 0.2, 5.5% | 4.3 | 0.1, 2.8% | 0.2, 4.5% | | | Plasma Mid · | 9.0 | 0.1, 0.7% | 0.2, 1.9% | 8.9 | 0.2, 2.1% | 0.2, 2.6% | 0.0 | 0.1, 1.0% | 0.2, 2.0% | | | Plasma High | 14.7 | 0.2, 1.2% | 0.2, 1.4% | 14.5 | 0.3, 1:8% | 0.3, 1.9% | 14.5 | 0.2, 1.2% | 0.2, 1.3% | | ## In-House Precision: Serum vs. Plasma - ACE CK Reagent | CK mg/dL | ACE Mean | Within- Run | Total | Alera Mean | Within- Run | Total | Axcel Mean | Within -Run | Total | |----------------|-------------|----------------|------------|---------------|----------------|---------------|---------------|----------------|---------------| | Serum Low | 79 | 3.2, 4.0% | 3.2, 4.0% | 81 | 3.8, 4.7% | 4.1, 5.0% | 85 | 1.5, 1.7% | 2.3, 2.7% | | Serum Mid | 636 | 7.7, 1.2% | 30.9, 4.9% | 615 | 9.4, 1.5% | 28.6, 4.6% | 682 | 3.7, 0.5% | 31.4, 4.6% | | Serum High | 1176 | 17.4, 1.5% | 56.1, 4.8% | 1125 | 7.9, 0.7% | 55.5, 4.9% | 1255 | 7.2, 0.6% | 58.4, 4.7% | | Plasma Low | 61 | 2.8, 4.6% | 3.1, 5.1% | 65 | 1.8, 2.8% | 2.8, 4.4% | 66 | 1.8, 2.8% | 2.1, 3.2% | | Plasma Mid | 619 | 11.1, 1.8% | 25.8, 4.2% | 605 | 8.8, 1.5% | 32.4, 5.4% | 666 | 13.0, 2.0% | 36.5, 5.5% | | Plasma High | 1140 | 16.1, 1.4% | 57.1, 5.0% | 1111 | 14.4, 1.3% | 51.1, 4.6% | 1221 | 11.7, 1.0% | 54.7, 4.5% | {8}------------------------------------------------ #### Performance Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems In-House Matrix Comparison -Serum vs. Plasma Data: In-House Matrix Comparison: Serum vs. Plasma – ACE BUN/Urea Nitrogen Reagent . | System | Range | Results - Serum vs. Plasma | |-----------------------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ACE 95 pairs | 3-91 mg/dL | Slope: 0.979 Intercept: 0.4 Correlation: 0.9980 Std. Error Est: 1.2 Confidence Interval Slope: 0.966 to 0.992 Confidence Interval Intercept: 0.0 to 0.7 | | ACE Alera 96 pairs | 3-96 mg/dL | Slope: 1.009 Intercept: -0.1 Correlation: 0.9976 Std. Error Est: 1.4 Confidence Interval Slope: 0.995 to 1.023 Confidence Interval Intercept: -0.5 to 0.4 | | ACE Axcel 51 pairs | 3-100 mg/dL | Slope: 1.007 Intercept: 0.3 Correlation: 0.9944 Std. Error Est: 2.4 Confidence Interval Slope: 0.977 to 1.038 Confidence Interval Intercept: -0.7 to 1.4 | #### In-House Matrix Comparison: Serum vs. Plasma – ACE Creatinine Reagent | System | Range | Results - Serum vs. Plasma | |------------------------|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ACE 102 pairs | 0.37-22.12 mg/dL | Slope: 1.014 Intercept: -0.003 Correlation: 0.9974 Std. Error Est: 0.279 Confidence Interval Slope: 1.000 to 1.029 Confidence Interval Intercept: -0.068 to 0.062 | | ACE Alera 102 pairs | 0.41-23.15 mg/dL | Slope: 1.050 Intercept: -0.077 Correlation: 0.9984 Std. Error Est: 0.197 Confidence Interval Slope: 1.038 to 1.062 Confidence Interval Intercept: -0.124 to -0.029 | | ACE Axcel 55 pairs | 0.37-23.45 mg/dL | Slope: 1.003 Intercept: 0.005 Correlation: 0.9993 Std. Error Est: 0.197 Confidence Interval Slope: 0.993 to 1.013 Confidence Interval Intercept: -0.058 to 0.069 | {9}------------------------------------------------ #### Performance Data: In-House Matrix Comparison -Serum vs. Plasma #### In-House Matrix Comparison: Serum vs. Plasma – ACE Uric Acid Reagent | System | Range | Results - Serum vs. Plasma | |-----------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ACE 97 pairs | 2.5-14.0 mg/dL | Slope: 1.008 Intercept: -0.14 Correlation: 0.9906 Std. Error Est: 0.35 Confidence Interval Slope: 0.980 to 1.036 Confidence Interval Intercept: -0.34 to 0.06 | | ACE Alera 95 pairs | 2.5-14.4 mg/dL | Slope: 1.028 Intercept: -0.29 Correlation: 0.9836 Std. Error Est: 0.48 Confidence Interval. Slope: 0.989 to 1.066 Confidence Interval Intercept: -0.57 to -0.01 | | ACE Axcel 55 pairs | 1.8-15.6 mg/dL | Slope: 1.025 Intercept: -0.09 Correlation: 0.9879 Std. Error Est: 0.42 Confidence Interval Slope: 0.981 to 1.069 Confidence Interval Intercept: -0.39 to 0.21 | #### In-House Matrix Comparison: Serum vs. Plasma - ACE CK Reagent | System | Range | Results - Serum vs. Plasma | |-----------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ACE 94 pairs | 11-1234 U/L | Slope: 0.997 Intercept: -0.5 Correlation: 0.9965 Std. Error Est: 23.5 Confidence Interval Slope: 0.980 to 1.014 Confidence Interval Intercept: -6.3 to 5.2 | | ACE Alera 96 pairs | 14-1211 U/L | Slope: 0.978 Intercept: 0.1 Correlation: 0.9960 Std. Error Est: 22.1 Confidence Interval Slope: 0.960 to 0.996 Confidence Interval Intercept: -5.2 to 5.5 | | ACE Axcel 55 pairs | 17-1315 U/L | Slope: 1.006 Intercept: -0.50 Correlation: 0.9990 Std. Error Est: 13.24 Confidence Interval Slope: 0.993 to 1.019 Confidence Interval Intercept: -4.74 to 3.74 | {10}------------------------------------------------ #### POL - Precision for ACE and ACE Alera Clinical Chemistry Systems Data: Precision - · Performance POL (Note: Refer to previously cleared submission k113389 for ACE Axcel POL data) | BUN/Urea | | ACE Result | | | ACE Alera Result | | | |----------|--------|---------------|-----------------|-----------------|------------------|-----------------|-----------------| | | | mg/dL SD, %CV | | | mg/dL SD, %CV | | | | Lab | Sample | Mean | Within- Run | Total | Mean | Within- Run | Total | | In-House | 1 | 8 | 0.00 SD 0.0% | 0.30 SD 4.0% | 8 | 0.40 SD 5.5% | 0.60 SD 7.7% | | POL 1 | 1 | 8 | 0.30 SD 3.9% | 0.30 SD 3.9% | 9 | 0.40 SD 4.5% | 0.50 SD 6.2% | | POL 2 | 1 | 8 | 0.40 SD 4.4% | 0.50 SD 5.6% | 8 | 0.20 SD 2.8% | 0.40 SD 4.9% | | POL 3 | 1 | 8 | 0.30 SD 3.9% | 0.30 SD 3.9% | 9 | 0.30 SD 3.6% | 0.70 SD 8.3% | | In-House | 2 | 41 | 1.90 SD 4.7% | 2.00 SD 5.0% | 42 | 1.30 SD 3.2% | 1.60 SD 3.9% | | POL 1 | 2 | 43 | 0.40 SD 1.0% | 0.80 SD 1.9% | 43 | 1.40 SD 3.4% | 1.70 SD 4.0% | | POL 2 | 2 | 42 | 0.30 SD 0.7% | 1.40 SD 3.3% | 41 | 1.10 SD 2.7% | 1.80 SD 4.4% | | POL 3 | 2 | 42 | 1.00 SD 2.4% | 1.10 SD 2.6% | 44 | 0.70 SD 1.7% | 1.40 SD 3.3% | | In-House | 3 | 74 | 1.10 SD 1.5% | 2.40 SD 3.2% | 75 | 0.40 SD 0.5% | 2.00 SD 2.6% | | POL 1 | 3 | 75 | 1.30 SD 1.8% | 1.30 SD 1.8% | 76 | 1.20 SD 1.6% | 1.80 SD 2.4% | | POL 2 | 3 | 73 | 1.30 SD 1.8% | 2.30 SD 3.1% | 74 | 1.70 SD 2.3% | 2.80 SD 3.7% | | POL 3 | 3 | 76 | 1.20 SD 1.6% | 1.40 SD 1.9% | 76 | 1.10 SD 1.4% | 2.20 SD 2.9% | {11}------------------------------------------------ #### Performance Data at POL: # Precision - 1 · · . POL # POL - Precision for ACE and ACE Alera Clinical Chemistry Systems | Creatinine | | ACE Result mg/dL SD, %CV | | | ACE Alera Result mg/dL SD, %CV | | | |------------|--------|-----------------------------|-----------------|-----------------|-----------------------------------|-----------------|-----------------| | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | | In-House | 1 | 0.58 | 0.04 SD 6.4% | 0.05 SD 8.8% | 0.58 | 0.02 SD 3.2% | 0.03 SD 5.3% | | POL 1 | 1 | 0.51 | 0.03 SD 5.6% | 0.04 SD 8.4% | 0.53 | 0.03 SD 6.0% | 0.05 SD 9.3% | | POL 2 | 1 | 0.54 | 0.04 SD 6.9% | 0.05 SD 9.8% | 0.56 | 0.02 SD 4.2% | 0.03 SD 4.4% | | POL 3 | 1 | 0.53 | 0.04 SD 6.6% | 0.04 SD 7.5% | 0.55 | 0.02 SD 4.3% | 0.04 SD 6.3% | | In-House | 2 | 8.29 | 0.09 SD 1.0% | 0.32 SD 3.9% | 8.08 | 0.11 SD 1.3% | 0.28 SD 3.5% | | POL 1 | 2 | 7.97 | 0.08 SD 1.0% | 0.20 SD 2.5% | 7.84 | 0.08 SD 1.1% | 0.15 SD 1.9% | | POL 2 | 2 | 7.60 | 0.11 SD 1.4% | 0.43 SD 5.7% | 8.21 | 0.14 SD 1.7% | 0.23 SD 2.8% | | POL 3 | 2 | 7.89 | 0.11 SD 1.4% | 0.13 SD 1.7% | 7.98 | 0.09 SD 1.1% | 0.23 SD 2.9% | | In-House | 3 | 12.92 | 0.18 SD 1.4% | 0.46 SD 3.5% | 12.65 | 0.07 SD 0.5% | 0.42 SD 3.3% | | POL 1 | 3 | 12.42 | 0.23 SD 1.9% | 0.37SD 3.0% | 12.32 | 0.10 SD 0.9% | 0.42 SD 3.4% | | POL 2 | 3 | 11.67 | 0.22 SD 1.9% | 0.53 SD 4.5% | 12.81 | 0.31 SD 2.4% | 0.50 SD 3.9% | | POL 3 | 3 | 12.28 | 0.17 SD 1.4% | 0.18 SD 1.5% | 12.27 | 0.12 SD 1.0% | 0.44 SD 3.6% | - 12 {12}------------------------------------------------ # POL – Precision for ACE and ACE Alera Clinical Chemistry Systems #### Performance Data at POL: Precision -POL | Uric Acid | | | | ACE Result mg/dL SD, %CV | | | ACE Alera Result mg/dL SD, %CV | | |--------------|--------|------|--|-----------------------------|-----------------|------|-----------------------------------|-----------------| | Lab | Sample | Mean | | Within- Run | Total | Mean | Within- Run | Total | | In- House | 1 | 2.9 | | 0.19 SD 6.5% | 0.19 SD 6.5% | 2.9 | 0.10 SD 3.5% | 0.13 SD 4.5% | | POL 1 | 1 | 3.0 | | 0.05 SD 1.7% | 0.09 SD 3.1% | 3.0 | 0.15 SD 5.2% | 0.16 SD 5.3% | | POL 2 | 1 | 2.8 | | 0.10 SD 3.5% | 0.11 SD 4.0% | 2.9 | 0.09 SD 3.1% | 0.10 SD 3.6% | | POL 3 | 1 | 2.9 | | 0.06 SD 2.2% | 0.14 SD 5.0% | 3.2 | 0.05 SD 1.6% | 0.09 SD 2.9% | | In- House | 2 | 8.0 | | 0.13 SD 1.6% | 0.15 SD 1.9% | 8.0 | 0.05 SD 0.7% | 0.17 SD 2.1% | | POL 1 | 2 | 7.7 | | 0.05 SD 0.6% | 0.11 SD 1.4% | 7.6 | 0.13 SD 1.7% | 0.21 SD 2.8% | | POL 2 | 2 | 7.5 | | 0.13 SD 1.7% | 0.16 SD 2.2% | 7.5 | 0.08 SD 1.0% | 0.13 SD 1.8% | | POL 3 | 2 | 7.9 | | 0.10 SD 1.2% | 0.13 SD 1.7% | 7.9 | 0.07 SD 0.9% | 0.25 SD 3.1% | | In- House | 3 | 12.5 | | 0.35 SD 2.8% | 0.38 SD 3.0% | 12.7 | 0.18 SD 1.4% | 0.22 SD 1.7% | | POL 1 | 3 | 12.0 | | 0.13 SD 1.1% | 0.28 SD 2.4% | 11.9 | 0.14 SD 1.2% | 0.26 SD 2.2% | | POL 2 | 3 | 11.8 | | 0.29 SD 2.5% | 0.32 SD 2.7% | 11.6 | 0.27 SD 2.4% | 0.27 SD 2.4% | | POL 3 | 3 | 12.3 | | 0.11 SD 0.9% | 0.12 SD 1.0% | 12.2 | 0.15 SD 1.2% | 0.35 SD 2.9% | {13}------------------------------------------------ #### Performance Data at POL: Data at T.O.E. #### Precision -POL # POL - Precision for ACE and ACE Alera Clinical Chemistry Systems | CK | | | ACE Result mg/dL SD, %CV | | | ACE Alera Result mg/dL SD, %CV | | |----------|--------|------|-----------------------------|-----------------|------|-----------------------------------|------------------| | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | | In-House | 1 | 77 | 3.20 SD 4.2% | 4.00 SD 5.2% | 75 | 2.50 SD 3.3% | 3.30 SD 4.4% | | POL 1 | 1 | 70 | 1.40 SD 2.0% | 2.90 SD 4.1% | 73 | 1.40 SD 1.9% | 2.60 SD 3.6% | | POL 2 | 1 | 69 | 1.90 SD 2.7% | 3.00 SD 4.4% | 70 | 2.20 SD 3.2% | 3.50 SD 5.0% | | POL 3 | 1 | 79 | 2.60 SD 3.2% | 2.70 SD 3.4% | 70 | 2.10 SD 3.0% | 4.10 SD 5.9% | | In-House | 2 | 521 | 6.70 SD 1.3% | 7.20 SD 1.4% | 516 | 8.00 SD 1.5% | 8.10 SD 1.6% | | POL 1 | 2 | 568 | 4.90 SD 0.9% | 6.90 SD 1.2% | 567 | 10.00 SD 1.8% | 14.00 SD 2.5% | | POL 2 | 2 | 526 | 3.90 SD 0.7% | 9.20 SD 1.8% | 514 | 6.50 SD 1.3% | 8.80 SD 1.7% | | POL 3 | 2 | 540 | 4.00 SD 0.7% | 4.30 SD 0.8% | 559 | 6.90 SD 1.2% | 14.10 SD 2.5% | | In-House | 3 | 907 | 10.90SD 1.2% | 14.60SD 1.6% | 905 | 9.50 SD 1.1% | 14.00 SD 1.6% | | POL 1 | 3 | 967 | 22.00SD 2.3% | 22.70SD 2.3% | 995 | 7.60 SD 0.8% | 14.40 SD 1.4% | | POL 2 | 3 | 929 | 18.60SD 2.0% | 18.90SD 2.0% | 899 | 11.40SD 1.3% | 11.60SD 1.3% | | POL 3 | 3 | 950 | 7.80 SD 0.8% | 9.90 SD 1.0% | 977 | 13.00SD 1.3% | 19.60 SD 2.0% | : . . . . . {14}------------------------------------------------ | Performance Data: | | POL – Method Comparison for ACE Clinical Chemistry System | | | | |--------------------------------------|----------------------|-----------------------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------| | Method Comparison - POL on ACE | Reagent | Statistic | In-House ACE (x) vs. POL 1 ACE (y) | In-House ACE (x) vs. POL 2 ACE (y) | In-House ACE (x) vs. POL 3 ACE (y) | | | BUN | n | 53 | 54 | 54 | | | | Range | 3 to 88 | 3 to 88 | 3 to 88 | | | | Regression | $y = 1.034x - 0.1$ | $y = 1.025x + 0.0$ | $y = 1.031x + 0.0$ | | | | Correlation | 0.9989 | 0.9985 | 0.9990 | | | | Std. Error Est. | 0.9 | 1.1 | 0.9 | | | | CI Slope | 1.020 to 1.047 | 1.010 to 1.040 | 1.018 to 1.044 | | | | CI Intercept | -0.5 to 0.2 | -0.4 to 0.5 | -0.3 to 0.4 | | | Creatinine | n | 51 | 51 | 51 | | | | Range | 0.34 to 22.57 | 0.34 to 22.57 | 0.34 to 22.57 | | | | Regression | $y = 1.032x - 0.010$ | $y = 1.010x - 0.046$ | $y = 0.986x - 0.017$ | | | | Correlation | 0.9994 | 0.9997 | 0.9999 | | | | Std. Error Est. | 0.148 | 0.100 | 0.060 | | | | CI Slope | 1.022 to 1.042 | 1.003 to 1.016 | 0.982 to 0.990 | | | | CI Intercept | -0.057 to 0.037 | -0.078 to -0.014 | -0.036 to 0.002 | | | Uric Acid | n | 49 | 49 | 49 | | | | Range | 1.7 to 14.5 | 1.7 to 14.5 | 1.7 to 14.5 | | | | Regression | $y = 0.988x + 0.23$ | $y = 1.018x - 0.06$ | $y = 1.009x + 0.03$ | | | | Correlation | 0.9939 | 0.9957 | 0.9969 | | | | Std. Error Est. | 0.27 | 0.23 | 0.19 | | | | CI Slope | 0.956 to 1.020 | 0.991 to 1.046 | 0.985 to 1.032 | | | | CI Intercept | 0.01 to 0.45 | -0.25 to 0.13 | -0.13 to 0.19 | | | Creatinine kinase | n | 50 | 48 | 49 | | | | Range | 11 to 1204 | 11 to 1204 | 11 to 1204 | | | | Regression | $y = 1.010x - 7.7$ | $y = 0.989x - 8.0$ | $y = 0.986x - 1.8$ | | | | Correlation | 0.9976 | 0.9987 | 0.9996 | | | | Std. Error Est. | 19.2 | 13.9 | 7.7 | | | | CI Slope | 0.990 to 1.031 | 0.974 to 1.004 | 0.978 to 0.995 | | | | CI Intercept | -14.7 to -0.7 | -13.2 to -2.8 | -4.6 to 1.1 | . · : . : : 上一篇: . . . . 15 11 - 11 {15}------------------------------------------------ | Performance Data at POL: Method Comparison - POL on ACE Alera | Reagent | Statistic | In-House ACE (x) vs. POL 1 Alera (y) | In-House ACE (x) vs. POL 2 Alera (y) | In-House ACE (x) VS. POL 3 Alera (y) | |------------------------------------------------------------------------------|---------|-----------------|--------------------------------------------|--------------------------------------------|--------------------------------------------| | BUN | | n | 53 | 53 | 53 | | | | Range | 3 to 88 | 3 to 88 | 3 to 88 | | | | Regression | $y = 1.039x + 0.3$ | $y = 1.011x + 0.2$ | $y = 1.019x + 1.4$ | | | | Correlation | 0.9987 | 0.9990 | 0.9972 | | | | Std. Error Est. | 0.9 | 0.8 | 1.4 | | | | CI Slope | 1.024 to 1.053 | 0.998 to 1.023 | 0.997 to 1.040 | | | | CI Intercept | -0.1 to 0.6 | -0.1 to 0.6 | 0.4 to 1.6 | | Creatinine | | n | 51 | 51 | 51 | | | | Range | 0.34 to 22.57 | 0.34 to 22.57 | 0.34 to 22.57 | | | | Regression | $y = 0.987x - 0.012$ | $y = 1.041x - 0.038$ | $y = 1.000x - 0.033$ | | | | Correlation | 0.9993 | 0.9994 | 0.9986 | | | | Std. Error Est. | 0.149 | 0.149 | 0.220 | | | | CI Slope | 0.977 to 0.998 | 1.031 to 1.051 | 0.985 to 1.015 | | | | CI Intercept | -0.059 to 0.036 | -0.085 to 0.010 | -0.083 to 0.057 | | Uric acid | | n | 49 | 49 | 49 | | | | Range | 1.7 to 14.5 | 1.7 to 14.5 | 1.7 to 14.0 | | | | Regression | $y = 0.967x + 0.37$ | $y = 0.964x + 0.21$ | $y = 0.994x + 0.29$ | | | | Correlation | 0.9941 | 0.9951 | 0.9909 | | | | Std. Error Est. | 0.26 | 0.23 | 0.33 | | | | CI Slope | 0.936 to 0.998 | 0.936 to 0.992 | 0.955 to 1.034 | | | | CI Intercept | 0.16 to 0.58 | 0.02 to 0.40 | 0.02 to 0.56 | | Creatinine Kinase | | n | 50 | 49 | 50 | | | | Range | 11 to 1204 | 11 to 1204 | 11 to 1204 | | | | Regression | $y = 1.043x - 6.4$ | $y = 0.971x - 2.3$ | $y = 0.983x - 8.7$ | | | | Correlation | 0.9994 | 0.9995 | 0.9968 | | | | Std. Error Est. | 9.8 | 7.5 | 21.5 | | | | CI Slope | 1.032 to 1.053 | 0.962 to 0.980 | 0.960 to 1.006 | | | | CI Intercept | -9.9 to -2.8 | -5.1 to 0.5 | -16.5 to -0.9 | . and the comments of the comments of the comments of the comments of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : {16}------------------------------------------------ ## Performance Data: . - .. · ACE Alera ## Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Alera Clinical Chemistry Systems ## Detection Limits - ACE Alera Clinical Chemistry System | ACE Alera | BUN (mg/dL) | Creatinine (mg/dL) | Uric Acid (mg/dL) | CK (U/L) | |---------------|----------------|-----------------------|----------------------|-------------| | LoB | 1.53 | 0.14 | 1.11 | 4.68 | | LoD | 1.97 | 0.18 | 1.34 | 8.30 | | LoQ (claimed) | 3.0 | 0.33 | 1.50 | 11.0 | ## Linearity - ACE Alera Clinical Chemistry System | ACE Reagents | Low level tested | Upper level tested | Linear to: | Linear Regression Equation | Correlation Coefficients R^2 | |-----------------------|------------------------|-----------------------|------------|-------------------------------|------------------------------------| | BUN (mg/dL) | 0.7 | 108.7 | 100.0 | $y=1.011x + 0.1$ | 0.9991 | | Creatinine (mg/dL) | 0.2 | 32.4 | 25.0 | $y=1.002x + 0.06$ | 0.9981 | | Uric Acid (mg/dL) | 1.1 | 17.3 | 16.0 | $y=0.994x - 0.10$ | 0.9939 | | CK (U/L) | 10.0 | 1416.7 | 1350.0 | $y=1.053x - 2.6$ | 0.9975 | {17}------------------------------------------------ # Performance Data: ## Interferences - ACE Alera Clinical Chemistry System ACE Alera | ACE Alera | Icterus | Hemolysis | Lipemia (Intralipid)/ Triglycerides | Ascorbic Acid | |--------------|----------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------| | BUN | No significant interference at or below 70 mg/dL | No significant interference at or below 500 mg/dL | No significant interference at or below 2080 mg/dL Triglycerides | No significant interference at or below 6 mg/dL | | Creatinine | No significant interference at or below 6.0 mg/dL | No significant interference at or below 1000 mg/dL | No significant interference at or below 2080 mg/dL Triglycerides | . No significant interference at or below 6 mg/dL | | UA | No significant interference at or below 16.9 mg/dL | No significant interference at or below 125 mg/dL | No significant interference at or below 893 mg/dL Triglycerides | No significant interference at or below 1.313 mg/dL | | CK | No significant interference at or below 30 mg/dL | No significant interference at or below 125 mg/dL | No significant interference at or below 2372 mg/dL Triglycerides | No significant interference at or below 6 mg/dL | {18}------------------------------------------------ # Precision - ACE Alera Clinical Chemistry System Performance Data: ACE Alera | on ACE Alera | | Mean | Precision (SD, %CV) | | |---------------------|------|------|---------------------|------------| | | | | Within-Run | Total | | BUN mg/dL | Low | 15 | 0.3, 2.1% | 0.5, 3.1% | | BUN mg/dL | Mid | 42 | 0.7, 1.7% | 1.3, 3.0% | | BUN mg/dL | High | 74 | 1.5, 2.0% | 2.3, 3.2% | | Creatinine mg/dL | Low | 0.9 | 0.03, 3.9% | 0.08, 9.8% | | Creatinine mg/dL | Mid | 1.7 | 0.04, 2.4% | 0.12, 7.5% | | Creatinine mg/dL | High | 5.4 | 0.13, 2.5% | 0.22, 4.1% | | Uric Acid mg/dL | Low | 3.5 | 0.10, 3.0% | 0.18, 5.2% | | Uric Acid mg/dL | Mid | 6.0 | 0.14, 2.3% | 0.25, 4.1% | | Uric Acid mg/dL | High | 11.6 | 0.32, 2.8% | 0.55, 4.7% | | CK U/L | Low | 128 | 2.2, 1.7% | 3.8, 3.0% | | CK U/L | Mid | 378 | 6.8, 1.8% | 11.5, 3.0% | | CK U/L | High | 865 | 8.5, 1.0% | 16.2, 1.9% | {19}------------------------------------------------ | Method Comparison - ACE Alera Clinical Chemistry System | | | | | |---------------------------------------------------------|----------------|-----------------------|----------------------|----------------| | | BUN (mg/dL) | Creatinine (mg/dL) | Uric Acid (mg/dL) | CK (U/L) | | n | 53 | 51 | 50 | 49 | | Range | 3 - 88 | 0.34 - 22.57 | 1.7 - 14.5 | 11 - 1204 | | Slope | 1.000 | 1.016 | 0.992 | 0.991 | | Intercept | 0.1 | -0.002 | 0.05 | -1.3 | | Correlation Coefficient | 0.9988 | 0.9997 | 0.9978 | 0.9999 | | Std. Error | 0.9 | 0.111 | 0.17 | -1.3 | | CI Slope | 0.986 to 1.014 | 1.008 to 1.023 | 0.973 to 1.010 | 0.987 to 0.995 | | CI Intercept | -0.3 to 0.4 | -0.038 to 0.034 | -0.09 to 0.18 | -2.6 to 0.0 | . . and the comments of the comments of . . . . . {20}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/20/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The symbol is rendered in black, contrasting with the white background. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### May 21, 2013 Alfa Wassermann Diagnostic Technologies, LLC C/O Hyman Katz, Ph.D. 4 Henderson Drive WEST CALDWELL NJ 07006 Re: K123322 Trade/Device Name: ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, ACE CK Reagent Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: II Product Code: CDN, CGX, KNK, CGS Dated: March 07, 2013 Received: March 20. 2013 #### Dear Dr. Katz: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical, Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {21}------------------------------------------------ If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Carol C. Benson - S for Courtney H. Lias, Ph.D. Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {22}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k123322 Device Name: ACE BUN/Urea Reagent Indications for Use: The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Device Name: ACE Creatinine Reagent Indications for Use: The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only Prescription Use X (21 CFR Part 801 Subpart D) Over-The-Counter Use. (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of In Vitro Diagnostic and Radiological Health (OIR) YungWDChan-S Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k123322 Page 1 of 2 {23}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known): k123322 #### Device Name: ACE Uric Acid Reagent Indications for Use: The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. #### Device Name: ACE CK Reagent Indications for Use: The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Prescription Use X (21 CFR Part 801 Subpart D) #### AND/OR Over-The-Counter Use. (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic and Radiological Health (OIR) YungWDChan-S Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k123322 Page 2 of 2